Identity
- Trade Name
- SOLTIVE FDA UDI
- Generic Name
- General/multiple surgical solid-state laser system FDA UDI
- Device Name
- TFL FIBER STRIPPER, 200 MICRON, AUTOCLAVABLE FDA UDI
- Model / Reference
- TFL-AFS 200 FDA UDI
- Description
- TFL FIBER STRIPPER, 200 MICRON, AUTOCLAVABLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925044388 FDA UDI
- 510(k) Number
- K242191 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General/multiple surgical solid-state laser system
Soltive by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General/multiple surgical solid-state laser system.
- O35 — HYPER PHOTONICS SRL · Class II
- Dornier MedTech — Dornier MedTech GmbH · Class II
- Lumenis Pulse 120H — Lumenis · Class II
- LOTUS Ⅱ power cable — Laseroptek Co., Ltd · Class II
- DEKA LIPOAI — EL.EN. SPA · Class II
- Thuvera — IPG Medical Corporation · Class II
- ACCENTO — Bison Medical Co, Ltd. · Class II
- Lumenis Pulse 60H — Lumenis · Class II
Cleared under the same submission
K242191 also covers:
- Olympus — Gyrus Acmi, Inc.
- Olympus — Gyrus Acmi, Inc.
- Olympus — Gyrus Acmi, Inc.
- Olympus — Gyrus Acmi, Inc.
- Olympus — Gyrus Acmi, Inc.
- Olympus — Gyrus Acmi, Inc.
- SOLTIVE — Gyrus Acmi, Inc.
- SOLTIVE — Gyrus Acmi, Inc.
- SOLTIVE — Gyrus Acmi, Inc.
- SOLTIVE — Gyrus Acmi, Inc.
- SOLTIVE — Gyrus Acmi, Inc.
- SOLTIVE — Gyrus Acmi, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI e3d7181b-75bf-4d37-882d-b087351e2933 34 fields · synced May 30, 2026